Ganglionated Plexus Ablation For Treatment of Atrial Fibrillation

February 6, 2018 updated by: Spectrum Dynamics

A Pilot Study on the Role pf Ganglionated Plexus Ablation for Catheter Ablation of Atrial Fibrillation.

This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac camera will guide the GP ablation procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Catheter ablation procedures are nowadays routine procedures in patients with drug-refractory atrial fibrillation (AF). However, ablation success for patients even in the early stages of AF is currently only around 70% and may require multiple procedures.

The intrinsic cardiac autonomic nervous system (ANS), which forms a neural network, has been shown to be a critical element responsible for the initiation and maintenance of AF. Autonomic inputs to the heart converge at several locations; these convergence points are typically embedded in the epicardial fat pads and form ganglionated plexi (GP) that contain autonomic ganglia and nerves. In human hearts, there are at least 7 GP and the 4 major left atrial GP are located around the antrum of the pulmonary veins (PVs). High-frequency stimulation (HFS; 20 Hz, 10-150 V and pulse width 1-10 ms) can localize GP during an invasive electrophysiology (EP) study.

A novel dedicated cardiac nuclear imaging camera with solid-state detectors (D-SPECT, Spectrum Dynamics) has demonstrated significantly improved sensitivity and image resolution and can provide novel imaging information on previously 'invisible' structures like the GP. Using this 3D image information to guide GP ablation could significantly facilitate AF ablation and result in improved ablation outcomes.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • The Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Paroxysmal or early persistent atrial fibrillation with ongoing AF for less than 1 week
  • Able to give written informed consent
  • Age >18 years old and ≤ 80 years
  • Fulfil established clinical criteria for catheter ablation of atrial fibrillation
  • Normal left ventricular (LV) ejection fraction and no evidence of significant structural heart disease

Exclusion Criteria:

  • Reversible cause of atrial fibrillation
  • Recent cardiovascular event including transient ischaemic attack (TIA)
  • Intolerance or unwillingness to oral anticoagulation with Warfarin
  • Bleeding disorder
  • Contraindication to computed tomography (CT) scan
  • Presence of intracardiac thrombus
  • Vascular disorder preventing access to femoral veins
  • Cardiac congenital abnormality
  • Severe, life threatening non cardiac disease
  • Active malignant disease or recent (<5 years) malignant disease
  • Presence of atrial septal defect (ASD) or patent foramen ovale (PFO) closure device
  • Unable or unwilling to comply with follow-up requirements
  • Patients on amiodarone until less than 3 months prior to the screening visit
  • Left atrium size > 5.5 cm on parasternal diameter in transthoracic echocardiography (TTE)
  • Renal impairment
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Image guided GP ablation
Use of cardiac nuclear imaging data to guide GP ablation procedures.
Procedure: Image guided GP ablation
3D imaging data from the D-SPECT system will be used to visualise the GP and guide the location of catheter ablation sites during the electrophysiology procedure.
Other Names:
  • D-SPECT dedicated cardiac nuclear camera
Device: D-SPECT dedicated cardiac nuclear camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Termination of atrial fibrillation during image guided ablation
Time Frame: At the time of the ablation procedure.
At the time of the ablation procedure.
Freedom from atrial fibrillation/flutter/tachycardia (>30 seconds) off antiarrhythmic medication at the end of 12 months following the index ablation procedure.
Time Frame: 12 months post the index ablation procedure.
12 months post the index ablation procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds)
Time Frame: Up to 12 months from the index ablation procedure
Up to 12 months from the index ablation procedure
Freedom from atrial fibrillation on previously failed antiarrhythmic medication
Time Frame: 12 months from the index ablation procedure.
12 months from the index ablation procedure.
Atrial fibrillation/flutter/tachycardia (>30 seconds) burden at 12 months post the index ablation procedure.
Time Frame: 12 months from the index ablation procedure.
AF/flutter/tachycardia burden will be modelled as a continuous variable with the number of episodes recorded.
12 months from the index ablation procedure.
Left atrial transport function
Time Frame: 6 months and 12 months post the index ablation procedure
Left atrial transport function will be assessed by echo as a categorical variable with 3 categories; poor, moderately impaired and normal.
6 months and 12 months post the index ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Dynamics

Investigators

  • Principal Investigator: Sabine Ernst, MD, The Royal Brompton Hospital, London, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 14, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDRBH01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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